BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3002882 · Received March 13, 2013

    Report

    Report Number
    3006630150-2013-00371
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    November 26, 2010
    Report Date
    February 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE REPORTED IN THIS MDR FORM FALLS UNDER INVESTIGATIONAL DEVICE EXEMPTION (IDE) AND SHOULD NOT HAVE BEEN REPORTED ON A 3500A MDR FORM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING INCREASED INFLAMMATION PARAMETERS. THE PATIENT WAS GIVEN MEDICATION AND THE EVENT WAS RESOLVED. THE SYMPTOMS ARE BELIEVED TO BE PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING INCREASED INFLAMMATION PARAMETERS. THE PATIENT WAS GIVEN MEDICATION AND THE EVENT WAS RESOLVED. THE SYMPTOMS ARE BELIEVED TO BE PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104790 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION DB-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention